Global API Markets Overview

Developed countries and regions such as the United States, Japan, and Europe have stricter regulations on the research, production, and sale of pharmaceuticals, which fall under regulated markets. Regulated markets account for more than 75% of the global consumption of active pharmaceutical ingredients, with the U.S. accounting for over 40% of the demand. Furthermore, due to higher quality requirements from downstream formulation companies, prices for active pharmaceutical ingredients are higher in the U.S. and Europe, making these markets ideal for sales.
Looking at the regions supplying active pharmaceutical ingredients, the main areas are China, India, Italy, the United States, and other regions in Europe. The western European region, represented by Italy, was once the largest active pharmaceutical ingredient production base in the world. However, as the global market for active pharmaceutical ingredients has dispersed, the advantages of China and India in terms of environmental protection and labor costs have become more apparent, resulting in the market gradually shifting towards the Asia-Pacific region. Currently, China's active pharmaceutical ingredient production capacity accounts for 28% of the global total, ranking first worldwide. However, in regulated markets where cost-effectiveness is higher, India's share is second only to the United States, giving it a leading advantage.
In regulated markets represented by the United States and Europe, DMF and CEP respectively serve as the qualification proof for active pharmaceutical ingredient enterprises to supply the U.S. and EU markets. The number of DMFs and CEPs reflects the variety of active pharmaceutical ingredient products that can be supplied to the markets. As China and India's technology continues to improve, since 2009, both countries have far exceeded the number of DMF and CEP applications in the U.S., Japan, Italy, and other countries, showing continuous growth. The shift of the global active pharmaceutical ingredient market towards the Asia-Pacific region is expected to continue in the future.